Clinical FSP Quality Manager

IQVIA; Reading; Hybrid; GBP 50,000 - 70,000; Full time

Job summary

A leading global clinical research company is seeking a Quality Manager for a hybrid role based in Reading, UK. You will implement the global Quality Management Plan and support teams with compliance to enhance project delivery. Candidates should have a Bachelor's Degree, sound knowledge of ICH and GCP, along with strong organizational and communication skills. The position requires fluency in English and offers opportunities for professional development in a dynamic environment. Please note, this role is not eligible for UK visa sponsorship.

Qualifications

• Sound working knowledge of medical terminology and quality management processes.
• Knowledge of National and International Regulations in Drug Development.
• Ability to travel within the region/country.

Responsibilities

• Implement the global Quality Management Plan within the assignment.
• Support teams in managing non-compliance and quality issues.
• Prepare periodic reports on quality-related matters.

Skills

Good organizational skills

Interpersonal skills

Communication skills

Judgement and decision-making skills

Influencing skills

Negotiation skills

Computer skills including Microsoft Office

Problem-solving skills

Ability to lead a clinical team

Fluency in English

Education

Bachelor's Degree or equivalent qualification

Job description

Please note this is a hybrid position with a request to be at the Reading office twice per week.

Job Overview

This Quality Manager role is assigned to a designated sponsor. The purpose of this role is to work together with global Quality Management, Site Management, and other stakeholders in a joint effort to define the global Quality Plan, carry out, and adopt the plan according to the specific needs defined by the scope of assignment, to assist staff in improving compliance with relevant International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), Key Performance Indicators (KPIs), applicable regulatory requirements, and guidelines.

This role coordinates and oversees staff within the scope of the assignment, provides advice, and supports staff and other relevant key stakeholders with regard to quality control, risk management, and corrective/preventive actions.

Essential Functions

• Adopt and implement the global Quality Management Plan within the scope of the assignment, including: Planning and executing the Quality Management activities; Risk identification and assessment through data review and quality control processes; Providing support in risk mitigation, in planning corrective/preventive actions, and guidance for improvement; Supporting the assigned business line management and staff to enhance effectiveness.
• Cooperate closely with the relevant business and other stakeholders, support maintaining focus on quality in project delivery.
• Contribute to the development and implementation of a Delivery Unit/Sponsor specific Quality Management Plan and Risk Management Program, monitor the implementation and delivery.
• Provide advice and support to teams within the assigned business line and other key stakeholders on all aspects of Good Clinical Practice (GCP) compliance.
• Work in close cooperation with teams to manage non-compliance, quality issues, assist in planning corrective/preventive actions, as applicable according to Standard Operating Procedures (SOPs).
• Inform Quality Management, assigned business line, and Quality Assurance of quality issues according to SOPs.
• Work closely with Quality Assurance and assigned business staff in case of suspected misconduct, as required by the applicable SOPs.
• May provide assistance during audits and regulatory inspections to the teams to the extent agreed with Quality Management and as required by the applicable SOPs.
• Act as the primary contact for Quality Assurance on quality matters – on the level of the assignment, attend meetings/teleconferences.
• Prepare periodic reports to Head(s) of business lines on quality related matters, risk assessments and specific quality improvement initiatives.
• Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work, appraising performance and guiding professional development, rewarding and disciplining employees, addressing employee relations issues and resolving problems. Approve actions on human resources matters.
• Upon agreement with the line manager: Perform any other reasonable tasks as required by the role.

Qualifications

• Bachelor's Degree or equivalent qualification.
• Equivalent combination of education, training, and experience.
• Sound working knowledge of medical terminology, Standard Operating Procedures (SOPs), International Conference on Harmonization (ICH), Good Clinical Practice (GCP), applicable regulatory requirements, quality management processes.
• Knowledge of National and International Regulations and Drug Development processes.
• Knowledge of Clinical Research Organization (CRO) or Pharmaceutical industry operations.
• Knowledge of IQVIA corporate standards and SOPs.
• Good organizational, interpersonal and communication skills.
• Good judgement and decision-making skills.
• Strong influencing and negotiation skills.
• Strong computer skills including Microsoft Office applications.
• Excellent problem solving skills.
• Ability to travel within the region/country.
• Ability to lead and motivate a clinical team.
• Ability to establish and maintain effective working relationships with co-workers, managers and clients/customers.
• Fluent in English.

*Please note - this role is not eligible for UK visa sponsorship*

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com